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Trial record 1 of 1 for:    NCT00879814
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Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults

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ClinicalTrials.gov Identifier: NCT00879814
Recruitment Status : Completed
First Posted : April 13, 2009
Results First Posted : November 25, 2014
Last Update Posted : August 6, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 10, 2009
First Posted Date  ICMJE April 13, 2009
Results First Submitted Date  ICMJE November 17, 2014
Results First Posted Date  ICMJE November 25, 2014
Last Update Posted Date August 6, 2015
Study Start Date  ICMJE April 2009
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2014)
  • Percentage of Participants With at Least One Adverse Event (AE) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium). [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium). [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]). [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine). [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]). [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein). [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose). [ Time Frame: Baseline up to Month 7 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2009)
Adverse Event collection and safety laboratory evaluation [ Time Frame: 1 month post third vaccination ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2014)
Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT) [ Time Frame: Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2009)
Ig binding assay [ Time Frame: 3 months post third vaccination. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults
Official Title  ICMJE A Phase 1 Randomized, Open-label, Parallel-group, Active- And Placebo-controlled Study To Assess Safety And Tolerability Of 60, 120, And 200 Mcg Meningococcal Group B Rlp2086 Vaccine In Healthy Adult Subjects
Brief Summary The purpose of this study is to evaluate the safety and tolerability of an investigational meningococcal B rLP2086 vaccine in healthy adults.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Meningitis, Meningococcal
Intervention  ICMJE Biological: rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
Study Arms  ICMJE
  • Experimental: 1
    rLP2086 vaccine 60 mcg
    Intervention: Biological: rLP2086 vaccine or control
  • Experimental: 2
    rLP2086 vaccine 120 mcg
    Intervention: Biological: rLP2086 vaccine or control
  • Experimental: 3
    rLP2086 vaccine 200 mcg
    Intervention: Biological: rLP2086 vaccine or control
  • Active Comparator: 4
    Tdap vaccine - normal saline - normal saline
    Intervention: Biological: rLP2086 vaccine or control
Publications * Sheldon EA, Schwartz H, Jiang Q, Giardina PC, Perez JL. A phase 1, randomized, open-label, active-controlled trial to assess the safety of a meningococcal serogroup B bivalent rLP2086 vaccine in healthy adults. Hum Vaccin Immunother. 2012 Jul;8(7):888-95. doi: 10.4161/hv.19983. Epub 2012 Jul 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2009)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

A subject must meet the following inclusion criteria at screening (visit 1) and at randomization (visit 2) to be considered for enrollment in the study:

  • Male or female subjects between the ages of 18 and 40.
  • Healthy male or female subjects as determined by medical history, physical examination, and judgment of the investigator.
  • Male or female subject who is considered biologically capable of having children must agree to commit to the use of a reliable method of birth control for the duration of the study and for 30 days after early discontinuation. A subject is still biologically capable of having children, even if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.

In addition a subject must meet the following inclusion criteria at randomization (visit 2) to be considered for enrollment in the study. The referred blood and urinalysis tests (inclusion criterion 5) will be performed on a blood and urine sample taken at visit 1:

  • Female subjects of childbearing potential with a negative urine pregnancy test prior to study drug administration. Note: this criterion will apply to each vaccination visit and to the last study visit.
  • Laboratory blood and urinalysis tests results within the per-protocol normal ranges.
  • Able to be contacted by telephone during the study period. Note: this criterion will apply to each study visit.

Exclusion Criteria:

None

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00879814
Other Study ID Numbers  ICMJE 6108A1-1004
B1971004 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP